Endoscopic apposition devices are devices that can be used in the body of a patient without the need to make an external incision in the patient, the device being controlled externally of the patient by endoscopic means. The device may comprise a sewing or stapling device for use in flexible endoscopy, though it is also applicable to devices for use in rigid endoscopy. Such devices have been found to be useful in the treatments of the digestive system, with the endoscope being inserted through a patient's esophagus. In particular, such devices have been found useful in treating gastro-esophageal reflux disease (GERD). In a procedure for treating GERD, stitches are placed to form tissue plications at the junction of the esophagus and stomach. The minor anatomical change resulting from the plication formation appears to relieve the symptoms of GERD in some patients.
Sewing devices of this general type are described in, for example, U.S. Pat. Nos. 5,080,663 and 5,792,153, which are incorporated by reference herein. Those patents disclose a sewing device for passing a thread through a tissue portion, which comprises a hollow needle movable between a first position in which it is out of the tissue portion and a second position in which it passes through the tissue portion, and a thread carrier adapted to be attached to the thread and being receivable within the hollow needle. The sewing device comprises a body, which defines a cavity within which the tissue portion can be held by means of suction, and the hollow needle is mounted for movement in the body between the first and second positions.
Two particular embodiments are described a single stitch sewing device, and a multiple stitch sewing device. In the single stitch device the thread carrier is transported by the needle through the tissue as the latter passes from its first position to its second position. When the needle returns to its first position, the thread carrier is left behind in the distal end of the sewing capsule. In the multiple stitch device, the same procedure occurs, but it is followed by a further step in which the hollow needle travels from its first position to its second position, picks up the thread carrier, and returns it. A second stitch may be formed during the next step. The whole sequence of steps is repeated as many times as may be required to form the desired number of stitches.
After placement of the sutures through the tissue, the suture must be secured tightly by knots or by a mechanical locking device. U.S. application Ser. Nos. 10/220,413 (“Suture Clips, Delivery Devices and Methods”, filed Mar. 13, 2003) and 10/275,534 (“Tissue Capturing and Suturing Device and Method”, filed Nov. 6, 2002), which are incorporated by reference herein in their entirety, disclose mechanical locking devices for securing a suture in an internal body location that are deliverable by an endoscope. These applications correspond to PCT Publication Nos. WO 01/66001 and WO 01/89393, respectively. However, due to their large size, these systems require that the endoscope be removed from the patient in order for the delivery device to be navigated to the suture location.
Minimizing the number of intubations and reducing the procedure time during which the patient must be kept under conscious sedation are important considerations in any endoscopic procedure. Prior art suturing devices must be withdrawn from the patient for each successive stitch made with the single-stitch embodiment. The use of the devices is, thus, time consuming, cumbersome and of some risk to the patient due to the multiple intubations and danger of perforation of the esophagus. It would be desirable to provide an endoscopic tissue apposition device that minimizes procedure time and the number of intubations while still making and securing multiple stitches during the procedure.